Indication for XYNTHA

Xyntha® Antihemophilic Factor (Recombinant) is indicated in adults and children with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for control and prevention of bleeding episodes and for perioperative management.

XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.

Important Safety Information for XYNTHA

Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.

Inhibitors have been reported following administration of XYNTHA. Monitor patients for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests.

Clinical response to XYNTHA may vary. If bleeding is not controlled with the recommended dose of factor, determine the plasma level and administer a dose of XYNTHA sufficient to achieve clinical response. If the factor level does not increase or there is no response, suspect an inhibitor and perform appropriate testing.

Across all studies, the most common adverse reactions (≥10%) with XYNTHA in previously treated adult and pediatric patients were headache (26% of subjects), arthralgia (25%), fever (21%), and cough (11%). Other adverse reactions reported in ≥5% of subjects were diarrhea, vomiting, weakness, and nausea.

XYNTHA is an injectable medicine administered by intravenous (IV) infusion. Patients should be advised that local irritation may occur when infusing XYNTHA after reconstitution in XYNTHA® SOLOFUSE®.

Indication for BeneFix

BeneFix® Coagulation Factor IX (Recombinant) is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including peri-operative management.

BeneFix is NOT indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X), hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, or bleeding due to low levels of liver-dependent coagulation factors.

Important Safety Information for BeneFix

BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.

Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought.

BeneFix has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.

Development of activity-neutralizing antibodies has been detected in patients receiving factor IX products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed.

Inhibitors have been reported following administration of XYNTHA. Monitor patients for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests.

Clinical response to XYNTHA may vary. If bleeding is not controlled with the recommended dose of factor, determine the plasma level and administer a dose of XYNTHA sufficient to achieve clinical response. If the factor level does not increase or there is no response, suspect an inhibitor and perform appropriate testing.

Across all studies, the most common adverse reactions (≥10%) with XYNTHA in previously treated adult and pediatric patients were headache (26% of subjects), arthralgia (25%), fever (21%), and cough (11%). Other adverse reactions reported in ≥5% of subjects were diarrhea, vomiting, weakness, and nausea.

XYNTHA is an injectable medicine administered by intravenous (IV) infusion. Patients should be advised that local irritation may occur when infusing XYNTHA after reconstitution in® SOLOFUSE®.

Indication for XYNTHA

Xyntha® Antihemophilic Factor (Recombinant) is indicated in adults and children with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for control and prevention of bleeding episodes and for perioperative management.

XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.

Important Safety Information for BeneFix

BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.

Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought.

BeneFix has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.

Development of activity-neutralizing antibodies has been detected in patients receiving factor IX products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed.

The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.

Indication for BeneFix

BeneFix® Coagulation Factor IX (Recombinant) is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including peri-operative management.

BeneFix is NOT indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X), hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, or bleeding due to low levels of liver-dependent coagulation factors.